HB4033 S JUD AM #1
Johnson 7909
The Committee on the Judiciary moved to amend the bill by striking out everything after the enacting clause and inserting in lieu thereof the following:
That §30-5-12b of the Code of West Virginia, 1931, as amended, be amended and reenacted; and that §30-5-34 of said code be amended and reenacted, all to read as follows:
§30-5-12b. Definitions; selection of generic drug products; exceptions; records; labels; manufacturing standards; rules; notice of substitution; complaints; notice and hearing; immunity.
(a) As used in this section:
(1) "Brand name" means the proprietary or trade name selected by the manufacturer and placed upon a drug or drug product, its container, label or wrapping at the time of packaging.
(2) "Generic name" means the official title of a drug or drug combination for which a new drug application, or an abbreviated new drug application, has been approved by the United States Food and Drug Administration and is in effect.
(3) "Substitute" means to dispense without the prescriber's express authorization a therapeutically equivalent generic drug product in the place of the drug ordered or prescribed.
(4) "Equivalent" means drugs or drug products which are the same amounts of identical active ingredients and same dosage form and which will provide the same therapeutic efficacy and toxicity when administered to an individual and is approved by the United States Food and Drug Administration.
(b) A pharmacist who receives a prescription for a brand name drug or drug product shall substitute a less expensive equivalent generic name drug or drug product unless in the exercise of his or her professional judgment the pharmacist believes that the less expensive drug is not suitable for the particular patient: Provided, That no substitution may be made by the pharmacist where the prescribing practitioner indicates that, in his or her professional judgment, a specific brand name drug is medically necessary for a particular patient.
(c) A written prescription order shall permit the pharmacist to substitute an equivalent generic name drug or drug product except where the prescribing practitioner has indicated in his or her own handwriting the words "Brand Medically Necessary". The following sentence shall be printed on the prescription form. "This prescription may be filled with a generically equivalent drug product unless the words 'Brand Medically Necessary' are written, in the practitioner's own handwriting, on this prescription form.": Provided, That "Brand Medically Necessary" may be indicated on the prescription order other than in the prescribing practitioner's own handwriting unless otherwise required by federal mandate.
(d) A verbal prescription order shall permit the pharmacist to substitute an equivalent generic name drug or drug product except where the prescribing practitioner shall indicate to the pharmacist that the prescription is "Brand Necessary" or "Brand Medically Necessary". The pharmacist shall note the instructions on the file copy of the prescription or chart order form.
(e) No person may by trade rule, work rule,
contract or in any other way prohibit, restrict, limit or attempt to prohibit,
restrict or limit the making of a generic name substitution under the
provisions of this section. No employer or his or her agent may use coercion or
other means to interfere with the professional judgment of the pharmacist in
deciding which generic name drugs or drug products shall be stocked or
substituted: Provided, That this section shall not be construed to permit the
pharmacist to generally refuse to substitute less expensive therapeutically
equivalent generic drugs for brand name drugs and that any pharmacist so
refusing shall be subject to the penalties prescribed in section twenty-two
thirty-four of this article.
(f) A pharmacist may substitute a drug pursuant to the provisions of this section only where there will be a savings to the buyer. Where substitution is proper, pursuant to this section, or where the practitioner prescribes the drug by generic name, the pharmacist shall, consistent with his or her professional judgment, dispense the lowest retail cost, effective brand which is in stock.
(g) All savings in the retail price of the
prescription shall be passed on to the purchaser; these savings shall be equal
to the difference between the retail price of the brand name product and the
customary and usual price of the generic product substituted therefor:
Provided, That in no event shall such savings be less than the difference in
acquisition cost of the brand name product prescribed and the acquisition cost
of the substituted product.
(h) (g) Each
pharmacy shall maintain a record of any substitution of an equivalent generic
name drug product for a prescribed brand name drug product on the file copy of
a written, electronic or verbal prescription or chart order. Such record shall
include the manufacturer and generic name of the drug product selected.
(i) (h) All
drugs shall be labeled in accordance with the instructions of the practitioner.
(j) (i)
Unless the practitioner directs otherwise, the prescription label on all drugs
dispensed by the pharmacist shall indicate the generic name using abbreviations,
if necessary, and either the name of the manufacturer or packager, whichever is
applicable in the pharmacist's discretion. The same notation will be made on
the original prescription retained by the pharmacist.
(k) (j) A
pharmacist may not dispense a product under the provisions of this section
unless the manufacturer has shown that the drug has been manufactured with the
following minimum good manufacturing standards and practices by:
(1) Labeling products with the name of the original manufacturer and control number;
(2) Maintaining quality control standards equal to or greater than those of the United States Food and Drug Administration;
(3) Marking products with identification code or monogram; and
(4) Labeling products with an expiration date.
(l) (k) The
West Virginia Board of Pharmacy shall promulgate rules in accordance with the
provisions of chapter twenty-nine-a of this code which establish a formulary of
generic type and brand name drug products which are determined by the board to
demonstrate significant biological or therapeutic inequivalence and which, if
substituted, would pose a threat to the health and safety of patients receiving
prescription medication. The formulary shall be promulgated by the board within
ninety days of the date of passage of this section and may be amended in
accordance with the provisions of chapter twenty-nine-a of this code.
(m) (l) No
pharmacist shall substitute a generic-named therapeutically equivalent drug
product for a prescribed brand name drug product if the brand name drug product
or the generic drug type is listed on the formulary established by the West
Virginia Board of Pharmacy pursuant to this article or is found to be in
violation of the requirements of the United States Food and Drug
Administration.
(n) (m) Any
pharmacist who substitutes any drug shall, either personally or through his or
her agent, assistant or employee, notify the person presenting the prescription
of such substitution. The person presenting the prescription shall have the
right to refuse the substitution. Upon request the pharmacist shall relate the
retail price difference between the brand name and the drug substituted for it.
(o) (n)
Every pharmacy shall post in a prominent place that is in clear and
unobstructed public view, at or near the place where prescriptions are
dispensed, a sign which shall read: "West Virginia law requires
pharmacists to substitute a less expensive generic-named therapeutically
equivalent drug for a brand name drug, if available, unless you or your
physician direct otherwise." The sign shall be printed with lettering of
at least one and one-half inches in height with appropriate margins and spacing
as prescribed by the West Virginia Board of Pharmacy.
(p) (o) The
West Virginia Board of Pharmacy shall promulgate rules in accordance with the
provisions of chapter twenty-nine-a of this code setting standards for
substituted drug products, obtaining compliance with the provisions of this
section and enforcing the provisions of this section.
(q) (p) Any
person shall have the right to file a complaint with the West Virginia Board of
Pharmacy regarding any violation of the provisions of this article. Such
complaints shall be investigated by the Board of Pharmacy.
(r) (q)
Fifteen days after the board has notified, by registered mail, a person, firm,
corporation or copartnership that such person, firm, corporation or
copartnership is suspected of being in violation of a provision of this
section, the board shall hold a hearing on the matter. If, as a result of the
hearing, the board determines that a person, firm, corporation or copartnership
is violating any of the provisions of this section, it may, in addition to any
penalties prescribed by section twenty-two of this article, suspend or revoke
the permit of any person, firm, corporation or copartnership to operate a
pharmacy.
(s) (r) No
pharmacist or pharmacy complying with the provisions of this section
shall be liable in any way for the dispensing of a generic-named
therapeutically equivalent drug, substituted under the provisions of this
section, unless the generic-named therapeutically equivalent drug was
incorrectly substituted.
(t) (s) In
no event where the pharmacist substitutes a drug under the provisions of this
section shall the prescribing physician be liable in any action for loss,
damage, injury or death of any person occasioned by or arising from the use of
the substitute drug unless the original drug was incorrectly prescribed.
(u) (t)
Failure of a practitioner to specify that a specific brand name is necessary
for a particular patient shall not constitute evidence of negligence unless the
practitioner had reasonable cause to believe that the health of the patient
required the use of a certain product and no other.
§30-5-34. Criminal offenses.
When, as a result of an investigation under this
article or otherwise, the board has reason to believe that a person authorized
under this article has committed a criminal offense the board may bring its
information to the attention of an appropriate law-enforcement official.
(a) When, as a result of an investigation under this article or otherwise, the board has reason to believe that a person authorized under this article has committed a criminal offense under this article, the board may bring its information to the attention of an appropriate law-enforcement official.
(b) Any person who intentionally practices, or holds himself or herself out as qualified to practice pharmacist care or to assist in the practice of pharmacist care, or uses any title, word or abbreviation to indicate to or induce others to believe he or she is licensed to practice as a pharmacist or pharmacist technician without obtaining an active, valid West Virginia license to practice that profession; or
With a license that is:
(1) Expired, suspended or lapsed; or
(2) Inactive, revoked, suspended as a result of disciplinary action, or surrendered;
is guilty of a misdemeanor and, upon conviction thereof, shall be fined not more than ten thousand dollars.
Adopted
Rejected